[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619041":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":56,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":18,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of KwaZulu","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Participants in the intervention arm will be exposed to the following interventions:\n\n1. A revised referral pathway across tertiary, secondary and primary levels of care, integrated with existing policies;\n2. A psychosocial rehabilitation programme, including a manual and training and mentorship package, introduced to multidisciplinary teams and nursing staff in specialist, regional and district hospitals\n3. A psychosocial rehabilitation programme, including a manual and training and mentorship package, introduced to registered counsellors in PHC facilities\n4. Refresher training on management of severe mental health conditions for physicians and nurses in PHC facilities\n5. A community mental health education and detection toolkit and associated training package for community health worker outreach teams\n6. The Household Champion programme, a psychoeducation, empowerment and support programme to improve caregiver capacity and improve community resource linkages.",[13],"Behavioral: Multilevel psychosocial support for people living with severe mental illness and their caregivers",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Service users discharged from acute psychiatric hospitalization to households in the community receiving standard care (i.e. monthly procurement of medicines at the primary healthcare clinic), as well as exposure to improved referral pathways as well as psychosocial rehabilitation on hospital level.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Multilevel psychosocial support for people living with severe mental illness and their caregivers","The intervention is the product of a human-centred design process, involving a range of health system actors. The intervention entails 1) A revised, integrated referral pathway across tertiary, secondary and primary levels of care; 2) A psychosocial rehabilitation programme, introduced to multidisciplinary teams and nursing staff in specialist, regional and district hospitals; 3) A psychosocial rehabilitation programme, introduced to registered counsellors in PHC facilities; 4) Refresher training on management of severe mental health conditions for physicians and nurses in PHC facilities; 5) A community mental health education and detection toolkit and associated training package for community health worker outreach teams; 6) The Household Champion programme, a psychoeducation, empowerment and support programme to improve caregiver capacity for care.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"André Janse van Rensburg, PhD","CONTACT","+27312601569","jansevanrensburga@ukzn.ac.za",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Tasneem Kathree, PhD","Kathree@ukzn.ac.za",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Msunduzi Local Municipality","RECRUITING","Pietermaritzburg","KwaZulu-Natal","3201","South Africa","ZA",{"type":44,"coordinates":45},"Point",[46,47],30.39278,-29.61679,{"lat":47,"lon":46},[50,53],{"name":32,"role":28,"phone":51,"phoneExt":18,"email":52},"+27827869330","kathree@ukzn.ac.za",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Andre Van Rensburg, PhD","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[59,61,63],{"name":60,"class":6},"Columbia University",{"name":62,"class":6},"Universiteit Antwerpen",{"name":64,"class":6},"Medical Research Council, South Africa","100619041","feasibility-and-acceptability-of-an-intervention-to-support-people-with-severe-mental-illness-in-south-africa-100619041",false,"NCT07339462","Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa","Feasibility and Acceptability of Critical Time Intervention to Support People With Severe Mental Illness Following Post-acute Hospital Discharge in South Africa","MhINT Recovery","Service user inclusion criteria:\n\n* Adults (aged 18 years and above);\n* Being admitted to the psychiatric ward of a hospital for observation and treatment due to an acute psychiatric event, based on ICD diagnosis on patient charts according to the following criteria:\n\n  * F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders\n  * F30-39 Mood \\[affective\\] disorders with psychoses\n  * F30.2 Mania with psychotic symptoms\n  * F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms\n  * F31.5 Bipolar affective disorder, current episode severe depression with psychotic symptoms\n  * F32.3 Severe depressive episode with psychotic symptoms\n  * F33.3 Recurrent depressive disorder, current episode severe with psychotic symptoms\n* Determined by the attending psychiatrist to be discharged into community settings following appropriate recovery from the psychiatric event;\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu\n\nService user exclusion criteria:\n\n* Under 18 years of age\n* Are indicated by their chart history to have the following conditions:\n\n  * Active suicidal ideation\n  * Substance abuse or dependence as primary diagnosed psychiatric condition\n  * Personality disorders\n  * Serious cognitive or other sensorial impairment likely to preclude informed consent and reliable assessment\n* Does not reside with a caregiver\n* Does not reside within the geographic boundaries of uMgungundlovu\n\nCaregiver inclusion criteria\n\n* Adults (aged 18 years and above)\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu\n\nCaregiver exclusion criteria\n\n* Adults (aged 18 years and above)\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu","ALL","18 Years",{"count":76,"type":77},86,"ESTIMATED","INTERVENTIONAL",[80],"NA","Despite commendable progress in developing mental health systems in low-and-middle income countries, critical gaps remain, particularly the development of community-based systems of support for people living with severe mental illness (SMIs). This application will pilot a co-developed health system strengthening intervention programme in a South African district in order to determine its feasibility, appropriateness and limited efficacy in reducing readmission following discharge from acute psychiatric hospitalization. By generating preliminary data on the real-world implementation of a co-developed programme in low-resource contexts in South Africa, this application seeks to build on an existing foundation of research partnerships and local government collaboration to develop a transitional support intervention that could yield significant and tangible impacts on people living with SMIs in low-resource communities.",[83],"Mental Disorders, Severe",[85,86,87,88,89,90,91],"Severe mental illness","Community-based care","Family empowerment","Recovery","Hospital readmission","Deinstitutionalization","Integrated care","2026-01-13",{"date":94,"type":95},"2026-01-14","ACTUAL",{"date":97,"type":95},"2025-08-01",{"date":99,"type":77},"2026-08-31",{"name":5,"class":6},1]